Congress Instructs FDA On Nanotech Work, But Mum On Regulations

The recently passed user fee reauthorization includes a provision that directs FDA to evaluate nano-engineered products’ potential benefits and safety. Friends of the Earth says nanotech products are available “prematurely … without having enough safety data.”

Congressional instruction that FDA evaluate the safety of nanotechnology-engineered materials does little to slow the development and launch of nanotech-based nutritionals, toothpastes, sunscreens and other consumer goods, environmental advocates say.

In the recently passed user fee reauthorization – the Food and Drug Administration Safety and Innovation Act, S. 3187 – Congress included a provision that for the first time directs the agency to evaluate nano-engineered products’ potential benefits and safety.

S. 3187 set user fees for prescription drugs and medical devices for five years – fiscal 2013 through 2017 – and creates new programs for generic drugs and biosimilars. Neither chamber’s appropriation bill for the agency designates funding for nanotech research, though FDA receives funding from National Nanotechnology Initiative.

The nanotech provision is based on language from legislation Sens. Mark Pyror, D-Ark., and Ben Cardin, D-Md., introduced in 2011, the Nanotechnology Regulatory Science Act, to establish a regulatory science program within FDA to assess the health and safety of nanomaterials in drugs, medical devices and OTC consumer products including sunscreens and other personal care products.

The Woodrow Wilson International Center for Scholars’ Project on Emerging Nanotechnologies has identified oral care products, vitamins, supplements and other health and fitness products as the fastest growing area of nano-engineered consumer products.

In its most recent inventory of nanotech products published in March 2011 and including products from more than 30 countries, PEN reported that health and fitness products accounted for 56% of 1,300 products total. PEN also said its first inventory in 2006 contained 212 products and the number could reach 3,400 by 2020.

Congressional Nanotech Research Directions

In the user fee legislation, Congress instructs FDA to intensify and expand activities related to enhancing scientific knowledge regarding nanomaterials included or intended for inclusion in FDA-regulated products, and address issues relevant to the regulation of the products, including potential toxicity, potential benefit of new therapies, and effects on and interaction with biological systems. The bill suggests FDA accomplish those goals through activities including:

• assess scientific literature and data on general nanomaterial interactions with biological systems and on specific nanomaterials of concern to FDA
• cooperate with other federal agencies to develop and organize information using databases and models that will facilitate the identification of generalized principles and characteristics regarding the behavior of classes of nanomaterials with biological systems
• promote FDA programs and participate in collaborative efforts to further understanding of the science of novel properties of nanomaterials that might contribute to toxicity
• promote and participate in collaborative efforts to further understanding of measurement and detection methods for nanomaterials
• collect, synthesize, interpret and disseminate scientific information and data related to the interactions of nanomaterials with biological systems
• build scientific expertise on nanomaterials within the agency, including field and laboratory expertise, for monitoring the production and presence of nanomaterials in domestic and imported products
• ensure ongoing training, as well as dissemination of new information within FDA’s centers, and more broadly across the agency, to ensure timely, informed consideration of the most current science pertaining to nanomaterials
• participate in international and national consensus standards activities pertaining to nanomaterials.

Urgency For Regulation Missing

The Friends of the Earth group long has recommended that FDA, other federal agencies and regulators in other countries, develop and impose regulations on the use of nanomaterials in consumer products. The S. 3187 provision encourages but does not satisfy the group.

“I still don’t see the urgency that we need,” said Ian Illuminato, FOE’s health and environment campaigner.

“What we’ve been calling for is for the precautionary principle to be upheld so that we can know a lot more about these products and the potential safety issues before they end up on the market. We now know that we have thousands of different kinds of nanomaterials in various types of products,” Illuminato said in an interview.

He pointed out that while no regulations have been imposed on their use, at least one federal agency – the Department of Energy – advises care when handling nanomaterials. The agency’s website includes this statement: “Nanoparticulates can exhibit unusual reactivity and toxicity. Avoid breathing dust, ingestion and skin contact.”

Illuminato suggested that consumer product manufacturers, too, should want federal agencies to establish nanotech-related regulations.

“I think any business that truly wants to be sustainable … would want the government to look into this. They would want to work with government to make sure they’re on the right track because liability is definitely an issue when we’re dealing with nanomaterials we know so very little about,” he said.

Although the selection of nano-engineered products available to consumers is growing rapidly, firms “in our opinion are prematurely marketing products without having enough safety data to really substantiate the safety,” Illuminato added.

FOE also points out that health problems caused by exposure to asbestos were not known until some 30 years after the material was used widely in consumer products as well as in industrial applications.

“It was this kind of wonder technology that 30 years later we realized actually kills poeple and is extremely toxic,” Illuminato said.

Appropriators Omit Nanotech Research Funding

Despite Pryor and Cardin’s emphasis on prioritizing nanotech research, the fiscal 2013 FDA budget the Senate Appropriations Committee passed in April does not include line-item funding for the agency’s nanotechnology work (Also see "Senate Appropriators Call For Botanical Identity Testing Guidance" - Pink Sheet, 7 May, 2012.).

However, the full committee’s report, reflecting Pyror’s work as a member of the Agriculture/Rural/FDA subcommittee, notes support for the agency’s nanotechnology efforts.

The committee “supports FDA in its mission to expand upon current research in nanotechnology” and in the “development of a Nanotechnology Core Center to … support nanotechnology toxicity studies, develop analytical tools to quantify nanomaterials in complex matrices, and develop procedures for characterizing nanomaterials in FDA-regulated products,” according to the report published with the bill, S. 2375.

FDA’s nanotechnology work did not receive similar attention in the House, where appropriators passed their fiscal 2013 Agriculture/Rural/FDA bill, H.R. 5973, in June. Like the Senate bill, H.R. 5973 did not specify funding for FDA’s nanotech research; but unlike the Senate appropriators’ report, the House members did not note nanotechnology in their report.

For the fiscal year that begins Oct. 1, H.R. 5973 allocates $2.48 billion in FDA’s direct appropriation – $16.3 million less than in fiscal 2012, after accounting for the information technology – and a total of $3.835 billion including user fees. S. 2375 includes a total agency budget of $3.9 billion, with $2.53 billion from direct funding (Also see "House, Senate Differ In Treating FDA China Syndrome" - Pink Sheet, 9 Jul, 2012.).

Nano-Slim Chances For Budget Increase

FDA and 25 other federal agencies already participate in the National Nanotechnology Initiative, which coordinates federal research and development. In addition to collaborative programs with other agencies, the primary areas of the agency’s nanotechnology work are scientific staff development, professional training and laboratory and product testing capacity.

FDA in June 2011 published a broad draft guidance on nanotechnology in regulated products that the agency said is a starting point in the regulation of engineered nanomaterials (Also see "FDA Nanotech Guidance Takes Small Step Forward" - Pink Sheet, 13 Jun, 2011.).

The Obama administration’s fiscal 2013 request for science program budgets included $1.8 billion for NNI, a $70 million increase from the 2012 enacted level. But increasing spending for nanotech or any other research and development programs faces long odds in this session of Congress. With all House seats and one-third of the Senate up for election, current members seeking re-election with many voters concerned about tight economic conditions likely will not support R&D budget hikes in fiscal 2013 appropriations.

In addition, FDA will face a sequester trigger under the deficit-reduction bill passed in 2011 that would result in a cut of 7.8% – or $2.4 billion – that would begin Jan. 2 if Congress fails to pass a budget. Congress uses budget sequestration to set aside funding equal to the difference between a cap set in a budget resolution and the amount actually appropriated to an agency.

Nanotech Big As Job Creator

Pryor and Cardin each represent a state that is home to a facility where FDA could conduct the scientific studies required under the bill – the National Center for Toxicological Research in Jefferson, Ark., and the agency’s consolidated headquarters at White Oak, Md., according to the two Democrats, who promoted their states for nanotech research in a June 27 joint release.

Pryor said there is “little independent research to show whether” nano-engineered products are safe. The user fee bill provision “provides an opportunity for the FDA to focus more on these health and safety studies,” he said, adding that “NCTR is an ideal candidate to take the lead in this arena.”

“The high-tech infrastructure at … White Oak provides the FDA with an opportunity for innovation to meet challenges in nanotechnology product safety,” Cardin said. He pointed out that nanotechnology “has grown to be indispensable in our daily lives” and it is essential that we fully assess, understand and address any risks that nanotechnology may pose to safety, public health and our environment.”

Pryor and Cardin noted more than 1,300 nanotech consumer products are available and that, according to a 2010 National Science Foundation estimate, nanotechnology-based products would contribute 2 million jobs and $1 trillion dollars in revenue to the global economy by 2015.